Abstract: :
Purpose: To report 3–year findings of a 5–year postmarketingsurveillance study of adverse events associated with latanoprost0.005% versus usual care.Methods: In this multinational, open–label, safety study,latanoprost–naive patients with open–angle glaucomaor ocular hypertension who required a change in therapy wererandomly assigned (2:1) to latanoprost administered once dailyor to usual care. Investigators selected usual care therapyand could modify the therapy of any patient in either randomizationgroup if intraocular pressure (IOP) was not sufficiently controlled.All patients were examined at baseline and every 6 months. Patientsrandomized or switched to latanoprost had iris photography priorto initiating latanoprost and at all subsequent visits. Themain safety endpoints were the occurrence of serious adverseevents, serious adverse drug reactions, and changes in pigmentationor eyelashes.Results: The randomized population included 5848 patients (latanoprost,3933; usual care, 1915); 4691 patients received latanoprostat some time during the study. IOP levels were reduced frombaseline in both randomized groups. New occurrences of cornealerosions, iritis/uveitis, or macular edema were seen in <2.3%of patients in either randomization group. Serious adverse drugreactions were reported in 14 patients (0.36%) randomized tolatanoprost and 6 (0.31%) randomized to usual care; 3 usualcare patients also received latanoprost, yielding 17 seriousadverse drug reactions for the total latanoprost population(0.36%). In the total latanoprost population, 10 patients (0.21%)discontinued treatment due to a serious adverse drug reactionand 3 (0.06%) discontinued the study. Investigators judged that<10% of the latanoprost population had increased pigmentationof the iris or periorbital skin, while about 35% had eyelashchanges; most (>85%) changes occurred within the first 24months. None of the 17 patients with serious adverse drug reactionshad increased iris pigmentation.Conclusion: Latanoprost is safe over 3–years of treatmentwith no evidence of possible long–term consequences ofincreased iris pigmentation. December 1, 2003